Application for an exemption from CE marking for medical devices

It is only permitted to market and use medical devices that fulfill the safety requirements established according to the Medical Devices Act No. 132/2020 and the regulations which have a basis in that law. This requirement entails, among other things, that medical devices shall be CE-marked and that the manufacturer has issued an EU Declaration of Conformity for the device. Lyfjastofnun has the authority to grant a temporary exemption from the aforementioned requirements for individual medical devices, in accordance with Article 59 of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, following a duly justified request for the use of a device in the interest of public health or the safety and health of patients. Exemptions are granted for a short term, i.e., while a manufacturer is in the conformity assessment process or while a comparable CE-marked device is being sought on the market.

Lyfjastofnun draws attention to the fact that the agency is obliged to formally notify the EFTA Surveillance Authority (ESA), the EU Commission, and other member states of the Agreement on the European Economic Area regarding all requests for exemptions from CE-marking. According to the aforementioned, the marketing and use of medical devices without CE-marking is prohibited without the approval of Lyfjastofnun.

An application for an exemption from CE-marking must contain a justification from a healthcare institution or a healthcare professional. This justification must include an assessment of the need for the medical device in the interest of public health and the safety or health of patients, and appropriate supporting documentation shall be included, including but not limited to a declaration from the device manufacturer regarding the purpose and risk class of the device, instructions for use, evidence of restricted access to comparable CE-marked products, the party responsible for incident reporting during use, and risks associated with incorrect use, etc. Lyfjastofnun draws attention to the obligations of those who receive an exemption from CE-marking to report all incidents related to the device to the agency.

Cost

Notice is also given that a fee, according to the current tariff, is charged for exemptions from requirements such as these.